Description:
- Conduct regulatory review processes for all investigator-initiated regulated research submitted to the
Research Ethics Board (REB) and Health Canada for review
- Conduct comprehensive centralized review and approval for all CHEO investigator-initiated applications, and ongoing communications/submissions to Health Canada to ensure accuracy and facilitate regulatory compliance
- Facilitate regulatory inspections across the Institution by ensuring research teams and hospital support areas are prepared
- Act as a consultant/expert resource to advise, guide, educate and train the CHEO clinical research community regarding methods to maintain high standards of quality research, and the mitigate potential risks arising from the conduct of clinical research, by sharing and educating staff about regulations, guidelines, and best practices
- Communicate and promote the use of institution-wide standard operating procedures for the conduct of clinical research
- Develop and maintain templates and resources to guide clinical research staff in the conduct of clinical research to facilitate regulatory compliance
- Liaise with research team members (locally and/or at study sites), REB staff, CHEO Grants, Contracts and Finance staff, study sponsors and others as required
- Identify ongoing education and support needs of the CHEO research community
- Deliver education sessions to clinical research staff on a variety of topics, including Clinical Trial
Applications, International Conference on Harmonization – Good Clinical Practice (ICH-GCP), SOPs, Part C Division 5, privacy regulations (provincial and federal), best practices, etc.
- Maintain current distribution lists for regulated researchers and research professionals
- Develop and maintain content for the CHEO RI Web pages
- Work with the CHEO Epic team to facilitate access for external monitors
- Perform other related duties as assigned by Manager
QUALIFICATIONS, SKILLS AND ABILITIES
- Bachelor’s degree Essential
- Advanced degree in Health Sciences, Health Care Administration, or another related field Preferred
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Preferred